Name: Predicase
Price: 199 USD

K-number	K201874
Device name	Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1
Applicant	Maquet Critical Care AB
Product code	CBK
Device class	Class II
Decision date	Apr 20, 2021
Decision	Substantially Equivalent
Regulation	868.5895

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1

Everything you need for a 510(k) submission. Nothing you don't.